MEDLINE MDSXB7584Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30193489107757), received between Apr 23, 2026 and Sep 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Split, Cut or Torn

  It was reported that "gloves are tearing" and "also some are out from the box before the patient use."

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913302 ↗
• MalfunctionSep 18, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829291 ↗
• MalfunctionSep 10, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722144 ↗
• MalfunctionSep 10, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718175 ↗
• MalfunctionSep 7, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650019 ↗
• MalfunctionSep 2, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571702 ↗
• MalfunctionSep 2, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570460 ↗
• MalfunctionAug 12, 2026Material Split, Cut or Torn

  It was reported that multiple gloves from the same box tearing upon donning or during use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225806 ↗
• MalfunctionAug 12, 2026Material Split, Cut or Torn

  It was reported that, gloves keep ripping either pulling from box and/or when putting them. Would estimate 1-2 times per day per day per day per day per nurse, with an uptick in the last few weeks.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217158 ↗
• MalfunctionAug 11, 2026Material Split, Cut or Torn

  It was reported that the gloves are ripping during patient care.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202146 ↗
• MalfunctionJun 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED FROM THE CUSTOMER THAT " GLOVES RIPPING WHILE PUTTING ON OR DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566127 ↗
• MalfunctionJun 8, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT "GLOVES RIPPING WHILE PUTTING ON OR DURING USE. GLOVES WERE USED WITH CAREGIVER, SO CONSIDERED A BIOHAZARD SINCE IT HAD CONTACT. THERE WAS NO CONTACT WITH BODILY FLUIDS OR HAZARDOUS DRUGS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437365 ↗
• MalfunctionApr 23, 2026Material Split, Cut or Torn

  ACCORDING TO THE CUSTOMER, WHEN TRYING TO GET GLOVES, THERE WERE SEVERAL GLOVES FROM THE SMALL SIZE GLOVES THAT WERE RIPPED WHEN GRABBING A PAIR FROM THE BOX OR RIPPED WHEN TRYING TO PUT THEM ON. I HAVE REMOVED THE GLOVES FROM THE ROOM AND REPLACED WITH A NEW BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24970232 ↗